Lifestyle Intervention Program in Overweight Medical Students

A Novel Lifestyle Intervention Program to Improve Body Composition and Chronic Disease Bio Markers in Overweight Medical Students: a Randomized Cross-over Trial

This study will be a randomized cross-over design over the course of 2 academic years. 40 subjects -20 overweight women and 20 over weight men will be recruited. Each subject will have body composition tested, blood lipid profile, and resting metabolic rate done in the beginning of the first academic year and at the end of the first academic year. The intervention group will receive activity trackers, diet counseling, and fitness counseling for one academic year. The second year, all outcome measures (a body scan, blood lipid profile, and resting metabolic rate) will be performed again at the start of the academic year 2, except the intervention group will now be the control group and the control group will now receive the same intervention. All final outcome measures will be performed at the end of the second year.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Behavioral: Lifestyle counseling

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Old Westbury, New York, United States, 11568
      • New York Institute of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female NYITCOM students between the ages of 18-35
• BMI ≥ 25.0
• Body fat % >19% for males; >33% for women (will be determined by body composition scan)
• Own their own smartphone

Exclusion Criteria:

• People who have used weight loss smartphone applications in the past 6 month
• People who have used an activity tracker in past 6 months
• Anyone who answers yes to one or more questions on the PAR-Q screen
• Any contraindication to having a duel x-ray body scan performed based on the American College of Radiology's practice guidelines

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; This group will receive a smart watch to track activity and diet. This group will also receive education on nutrition and exercise.	Behavioral: Lifestyle counseling; This group will receive online education modules to educate them on exercise prescription, nutrition and behavioral changes.
No Intervention: Control; This group will receive a smart watch to track activity only with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat percentage	Body composition	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step Count	Activity based on step count	4 months
Resting Metabolic Rate	Resting metabolic rate changes as per oxygen consumption	4 months
Total Cholesterol	fasting serum mg/dL	4 months
High Density Lipoproteins	fasting serum mg/dL	4 months
Low Density Lipoproteins	fasting serum mg/dL	4 months
Triglycerides	fasting serum mg/dL	4 months
Hemoglobin A1C	fasting plasma % of total hemoglobin	4 months

Collaborators and Investigators

• Sponsor: New York Institute of Technology
• Investigators: Principal Investigator: Joanne Donoghue, New York Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2018
• Primary Completion (Actual): April 25, 2021
• Study Completion (Actual): April 25, 2021

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: BHS-1333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No